Sterilization Program Management (Ethylene Oxide, Radiation, & Steam as well as new technologies)
Sterilization Process Optimization, Process Challenge Device Development and IFU Validation
Product Sterilization & Distribution Strategy Development
Validation Program Development & Execution — Clean Rooms, Packaging, & Sterilization
Contamination Control Programs including Environmental Corrective Actions
Microbiology Laboratory & Hospital Central Supply Gap Assessments
Customized Training Programs for Sterilization, Quality Assurance, Regulatory Affairs, & Risk Management
• AAMI/ANSI/ISO Sterilization (ISO 11135, ISO 11137, etc.)
• Medical Device Standards (ISO 14971)
• 21 CFR Part 820